Today is 2020-11-27

The Effects of Narrative Exposure Therapy on COVID-19 Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial
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注册号:

Registration number:

ChiCTR2000039369 

最近更新日期:

Date of Last Refreshed on:

2020-10-24 

注册时间:

Date of Registration:

2020-10-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

叙述暴露疗法对COVID-19创伤后应激障碍患者的影响:一项随机对照试验 

Public title:

The Effects of Narrative Exposure Therapy on COVID-19 Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

叙述暴露疗法对COVID-19创伤后应激障碍患者的影响:一项随机对照试验 

Scientific title:

The Effects of Narrative Exposure Therapy on COVID-19 Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

凡颖 

研究负责人:

凡颖 

Applicant:

Fan Ying 

Study leader:

Fan Ying 

申请注册联系人电话:

Applicant telephone:

+86 15172570346 

研究负责人电话:

Study leader's telephone:

+86 15172570346 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

893352976@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

893352976@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

湖北省襄阳市樊城区解放路襄遇小区3号楼2单元1101 

研究负责人通讯地址:

湖北省襄阳市樊城区解放路襄遇小区3号楼2单元1101 

Applicant address:

1101, Unit 2, Building 3, Xiangyu Community, Jiefang Road, Fancheng District, Xiangyang, Hubei, China 

Study leader's address:

1101, Unit 2, Building 3, Xiangyu Community, Jiefang Road, Fancheng District, Xiangyang, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

武汉大学健康学院 

Applicant's institution:

School of Health, Wuhan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

202014 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

襄州区人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Xiangzhou District People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-26 

伦理委员会联系人:

孙定文 

Contact Name of the ethic committee:

Sun Dingwen 

伦理委员会联系地址:

湖北省襄阳市襄州区航空路248号襄州区人民医院行政楼四楼502 

Contact Address of the ethic committee:

Room 502, Floor 4, Administrative Building, Xiangzhou District People's Hospital, 248 Hangkong Road, Xiangzhou District, Xiangyang, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

襄阳市中心医院 

Primary sponsor:

Xiangyang Central Hospital 

研究实施负责(组长)单位地址:

湖北省襄阳市襄州区航空路248号襄州区人民医院 

Primary sponsor's address:

248 Hangkong Road, Xiangzhou District, Xiangyang, Hubei, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北省

市(区县):

襄阳市

Country:

China

Province:

Hubei

City:

Xiangyang

单位(医院):

襄州区人民医院

具体地址:

湖北省襄阳市襄州区航空路248号

Institution
hospital:

Xiangzhou District People's Hospital

Address:

248 Hangkong Road, Xiangzhou District

国家:

中国

省(直辖市):

湖北省

市(区县):

襄阳市

Country:

China

Province:

Hubei

City:

Xiangyang city

单位(医院):

襄阳市中心医院

具体地址:

湖北省襄阳市襄城荆州街136号

Institution
hospital:

Xiangyang Central Hospital in Hubei Province

Address:

136 Jingzhou Street, Xiangcheng

国家:

中国

省(直辖市):

湖北省

市(区县):

襄阳市

Country:

China

Province:

Hubei

City:

Xiangyang

单位(医院):

襄阳市中医医院

具体地址:

襄阳市樊城区长征路24号

Institution
hospital:

Xiangyang Hospital of Traditional Chinese Medicine

Address:

24 Changzheng Road, Fancheng District

经费或物资来源:

襄州区人民医院 

Source(s) of funding:

Xiangzhou District People's Hospital 

研究疾病:

新型冠状病毒肺炎合并创伤后应激障碍 

Target disease:

COVID-19 Patients with Post-Traumatic Stress Disorder 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

筛查预出院COVID-19患者创伤后应激障碍患病率,探讨叙述性暴露疗法对创伤后应激障碍患者的影响。 

Objectives of Study:

To screen for the prevalence of PTSD among pre-discharged COVID-19 patients and explore the effects of narrative exposure therapy on patients experiencing PTSD. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

研究参与者纳入标准包括:a.根据2019年新型冠状病毒感染肺炎的诊断和临床管理(试验版本6或试验版本7)诊断为COVID-19;b. PCL-C评分≥50;c.愿意参与研究 

Inclusion criteria

1. diagnosed with COVID-19 according to the Diagnosis and Clinical Management of 2019 novel coronavirus infected pneumonia (trial version 6 or trial version 7); 2. score of PCL-C>=50; 3. willing to participate in the study.  

排除标准:

排除标准包括:a.有精神病史;b.不会使用互联网 

Exclusion criteria:

1. history of mental illness; 2. inability to use the internet. 

研究实施时间:

Study execute time:

From2020-02-28To 2020-06-03 

征募观察对象时间:

Recruiting time:

From2020-02-28To 2020-06-03 

干预措施:

Interventions:

组别:

干预组

样本量:

56

Group:

Experimental group

Sample size:

干预措施:

个性化心理干预加上叙事暴露疗法

干预措施代码:

Intervention:

Personalized psychological intervention plus narrative exposure therapy

Intervention code:

组别:

对照组

样本量:

55

Group:

control group

Sample size:

干预措施:

个性化心理干预

干预措施代码:

Intervention:

Personalized psychological intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

襄阳市 

Country:

China 

Province:

Hubei 

City:

Xiangyang 

单位(医院):

襄阳市中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

Xiangyang Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

襄阳市 

Country:

China 

Province:

Hubei 

City:

Xiangyang 

单位(医院):

襄阳市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Xiangyang Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

PCL-C评分

指标类型:

主要指标 

Outcome:

Photo - C grade

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

主要指标 

Outcome:

SAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

主要指标 

Outcome:

SDS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

主要指标 

Outcome:

PSQI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

主要指标 

Outcome:

PSQI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由责任护士抽签决定患者分组

Randomization Procedure (please state who generates the random number sequence and by what method):

The group of patients will be determined by drawing lots from the nurse in charge

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2020年10月

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

In October 2020

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-10-24
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